Cost-effectiveness analysis of different COVID-19 screening strategies based on rapid or laboratory-based SARS-CoV-2 antigen testing

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. e168 - e171

Published: Feb. 27, 2023

To the Editor, Now, in fourth year of coronavirus disease 2019 (COVID-19) pandemic, many important aspects have become clear concerning pathogenesis, clinical management, outcome and, last but not least, regarding diagnostic approach to severe acute respiratory syndrome 2 (SARS-CoV-2) infection.Although it is undeniable that consequences an SARS-CoV-2 infection general population are incomparably milder now compared period when virus initially spread worldwide from China [1], number daily COVID-19 diagnoses still very high.According World Health Organization (WHO), new or recurrent cases exceeds 200,000 February 2023 [2].We also must acknowledge this may be heavily underestimated for a variety reasons discussed elsewhere [3].Thus, strategies only relying on molecular testing, although remaining gold standard detecting SARS-CoV-2, imprudent given reference real-time reverse transcription polymerase chain reaction (RT-PCR) assays characterized by low throughput, long turnaround time and high cost [4], thus paving way using alternative solutions.Among various options, identification quantification antigens means rapid tests (RDT-Ag) laboratory-based immunoassays (LAB-Ag) represent valuable alternatives, endorsed both WHO [5] International Federation Clinical Chemistry Laboratory Medicine [6].Although we certainly recognize sensitivity these basically lower than (i.e., comprised between 70 80%) [7, 8], their usage initial "screening" patients provide saving precious human economic resources, though no comprehensive information exists confirm validity second claim best our knowledge.To end, carried out cost-effective analysis some potential protocols inclusive antigen tests.The study consisted series 294 (mean age, 45 ± 20 years; 55% females) presenting facility Pederzoli Hospital Peschiera del Garda (Verona, Italy), undergo routine testing.According local operating procedures (SOPs), all underwent testing (RDT-Ag, ∼30 min time; Fujirebio Espline SARS-CoV-2; Inc., Tokyo, Japan) enabling fast positive subjects, followed (RT-PCR, 4-6 h Altona Diagnostics RealStar SARSCoV-2 RT-PCR Kit; GmbH, Hamburg, Germany) Ag (LAB-Ag, 45-60 DiaSorin LIAISON Ag; DiaSorin, Saluggia, Italy) same nasopharyngeal sample.The specific

Language: Английский

---

A high throughput immuno-affinity mass spectrometry method for detection and quantitation of SARS-CoV-2 nucleoprotein in human saliva and its comparison with RT-PCR, RT-LAMP, and lateral flow rapid antigen test

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2024, Volume and Issue: 62(6), P. 1206 - 1216

Published: Jan. 22, 2024

Abstract Objectives Many reverse transcription polymerase chain reaction (RT-PCR) methods exist that can detect SARS-CoV-2 RNA in different matrices. RT-PCR is highly sensitive, although viral may be detected long after active infection has taken place. proteins have shorter detection windows hence their might more meaningful. Given salivary droplets represent a main source of transmission, we explored the and protein using four platforms including SISCAPA peptide immunoaffinity liquid chromatography-mass spectrometry (SISCAPA-LC-MS) polyclonal capture antibodies. Methods The SISCAPA-LC MS method was compared to RT-PCR, RT-loop-mediated isothermal amplification (RT-LAMP), lateral flow rapid antigen test (RAT) for virus material drool saliva 102 patients hospitalised with SARS-CoV-2. Cycle thresholds (Ct) ( E gene) were RT-LAMP time-to-positive (TTP) NE Orf1a genes), RAT optical densitometry measurements (test line/control line ratio) SISCAPA-LC-MS protein. Results showed low sensitivity (37.7 %) but high specificity (89.8 %). lower (24.5 (100 had (83.0 (100.0 At initial loads (<20 Ct), results obtained correlated (R 2 0.57, p-value 0.002). Conclusions Detection nucleoprotein less frequent than RNA. allowed processing multiple samples <150 min scalable, enabling throughput.

Language: Английский

---

Analysis and assessment of biomedical scientists’ needs for clinical laboratory: activity-based management as an evaluation methodology

Frontiers in Bioengineering and Biotechnology, Journal Year: 2025, Volume and Issue: 13

Published: May 13, 2025

Introduction Healthcare systems have to protect citizens’ health by developing models combining concepts of efficiency, effectiveness and quality care. The post-Covid-19 pandemic context has highlighted the relevance efficiently managing allocating human resources. In this scenario, analysis calculation personnel needs take on strategic importance. project aims suggest a methodology define Biomedical Scientists. goal is create standard model adaptable different contexts. Methods This project, developed in cooperation with Italian Society Clinical Biochemistry Molecular Biology, created new format following “Activity Based Management” approach. It characterized continuous improvements, based processes, broken down into sub-processes activities. After phase development, application contexts, such as biochemistry hematology sectors, followed. Results suggested allows estimate number Full Time Equivalents necessary for management laboratory processes. Furthermore, an objective analytical data obtained, because it timely numerical surveys that included productivity execution times Discussion Using had relevant impact their possible improvement. method allowed evaluate improve “extra-production” activities, often underestimated but having decisive role process. proposed can be considered valid tool managers analyze evaluating Scientists laboratory. Activity Management us obtain precise and, at same time, focus main any clinical laboratory: value patient supporting diagnosis treatment paths through safe reliable tests, which depends correct allocation

Language: Английский

---

Differential Diagnosis in the Management of Acute Respiratory Infections through Point-of-Care Rapid Testing in a Post-Pandemic Scenario in Latin America: Special Focus on COVID-19, Influenza, and Respiratory Syncytial Virus

COVID, Journal Year: 2024, Volume and Issue: 4(2), P. 221 - 260

Published: Feb. 10, 2024

This review provides a comprehensive summary of evidence to explore the role and value differential diagnosis in management Acute Respiratory Infections (ARIs) through point-of-care (POC) rapid testing post-pandemic scenario, paying particular attention coronavirus disease 2019 (COVID-19), influenza, respiratory syncytial virus (RSV). The document builds on literature policies process validation feedback by group seven experts from Latin America (LATAM). Evidence was collected understand scientific policy perspectives ARIs POC testing, with focus countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru. indicates that can serve improve ARI case management, epidemiological surveillance, research innovation, evidence-based decision-making. With multiple types tests available for POC, decisions regarding which use require consideration purpose, resources, test characteristics accuracy, accessibility, affordability, results turnaround time. Based understanding current situation, this set recommendations implementation LATAM, supporting decision-making guiding efforts broad range stakeholders.

Language: Английский

---

Peri-infection titers of neutralizing and binding antibodies as a predictor of COVID-19 breakthrough infections in vaccinated healthcare professionals: importance of the timing

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. 1670 - 1675

Published: March 31, 2023

Abstract Objectives The BNT162b2 messenger RNA vaccine is highly effective in reducing COVID‐19 infection, hospitalization and death. However, many subjects developed a breakthrough infection despite full vaccination scheme. Since the waned efficacy of mRNA vaccines correlated with decrease antibodies occurring over time, we aimed at evaluating whether lower levels were associated an increased risk cohort that received three doses. Methods Total binding against RBD S1 subunit (Roche Diagnostics, Machelen, Belgium) neutralizing using Omicron B.1.1.529 variant pseudovirus measured. Based on individual kinetic curves, antibody titer each subject was interpolated just before compared to matched-control group did not develop infection. Results Lower total observed control (6.900 [95% CI; 5.101–9.470] vs. 11.395 BAU/mL [8.627–15.050] [p=0.0301] 26.6 [18.0–39.3] 59.5 dilution −1 [32.3–110] [p=0.0042], respectively). difference between mostly for months after homologous booster administration (46.5 [18.2–119] 381 [285–509] [p=0.0156]). Considering measurement 3 months, there no significant (p=0.4375). Conclusions In conclusion, our results showed had controls. noticeable considering antibodies, especially infections administration.

Language: Английский

---

Kinetics and ability of binding antibody and surrogate virus neutralization tests to predict neutralizing antibodies against the SARS-CoV-2 Omicron variant following BNT162b2 booster administration

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(10), P. 1875 - 1885

Published: April 21, 2023

Abstract Objectives To assess the long-term humoral immunity induced by booster administration, as well ability of binding antibody and surrogate virus neutralization tests (sVNT) to predict neutralizing antibodies (NAbs) against SARS-CoV-2 Omicron variant. Methods A total 269 sera samples were analyzed from 64 healthcare workers who had received a homologous dose BNT162b2. Neutralizing assessed sVNT anti-RBD IgG measured with sCOVG assay (Siemens Healthineers ® ) at five timepoints; before up 6 months following booster. Antibody titers correlated BA.1 variant obtained pseudovirus test (pVNT) reference method. Results While Wild-type percentage inhibition (POI) remained above 98.6% throughout follow-up period after NAbs pVNT showed respectively 3.4-fold 13.3-fold decrease compared peak reached day 14. followed steady decline until reaching POI 53.4%. Anti-RBD assays strongly (r=0.90) performed similarly presence (area under ROC: 0.82 for both assays). In addition, new adapted cut-off values (>1,276 BAU/mL) (POI>46.6%) found be better predictors activity. Conclusions This study significant drop in administration. highly could activity moderate performance.

Language: Английский

---

Pooled analysis of laboratory-based SARS-CoV-2 antigen immunoassays

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(9), P. e165 - e167

Published: Jan. 12, 2023

Language: Английский

---

Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(8), P. 1506 - 1510

Published: March 8, 2023

Abstract Objectives Given that SARS-CoV-2 antigen tests will represent a pillar for supporting or surrogating molecular testing in the endemic period, we report here clinical performance of new SNIBE Maglumi fully-automated chemiluminescent immunoassay (MAG-CLIA Ag). Methods The study population consisted 181 subjects (mean age 61 ± 21 years; 92 females) undergoing coronavirus disease 2019 (COVID-19) at local diagnostic facility, from December 2022 to February 2023. Routine practice involved collection double nostril nasopharyngeal swab, analyzed duplicate with Ag) and (Altona Diagnostics RealStar RT-PCR Kit) tests. Results A significant Spearman’s correlation was found between MAG-CLIA Ag mean Ct values E S genes (r=−0.95; p<0.001). In all samples, area under curve (AUC) 0.86 (95% CI, 0.81–0.90), 0.71 sensitivity 1.00 specificity 7 ng/L cut-off, increasing 0.98 0.96–1.00) AUC 0.96 (with 0.97 specificity) high viral load samples. When N protein concentration replaced raw instrumental readings (i.e., relative light units [RLU]), samples increased 0.94. RLU value 945 associated 88.4% accuracy, 0.85 sensitivity, 0.95 specificity, 0.77 negative predictive (NPV) positive (PPV), respectively. Conclusions We satisfactory analytical Ag, which could be used as surrogate identifying Broadening reportable range may generate even better performance.

Language: Английский

---

Clinical Chemistry Laboratory Medicine in the post-acute COVID-19 era

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2024, Volume and Issue: 62(9), P. 1651 - 1652

Published: July 5, 2024

Language: Английский

---

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)

Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown

Published: March 29, 2023

Abstract Background . This article presents a critical literature review and meta-analysis of diagnostic performance Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), rapid test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages point-of-care testing those laboratory-based immunoassay. Methods: We conduced an electronic search in PubMed Scopus keywords "Quidel" OR “SOFIA” AND “Antigen” "SARS-CoV-2" “COVID-19” up to March 24, 2023, identifying articles containing data on accuracy FIA diagnosing acute SARS-CoV-2 infections. selected where was compared that reference molecular assay, sufficient information constructing 2×2 table. Results: A total number 18 (48165 samples; 9.8% positive at testing) were included this meta-analysis, averaging 24 sample cohorts. The (summary area under curve), sensitivity specificity 0.980, 0.76 1.00 all samples, 0.981, 0.81 0.99 samples collected from symptomatic patients, 0.931, 0.55 taken asymptomatic 0.960, 0.77 mixed cohorts respectively. Minor clinically negligible differences could be found by comparing results nasal nasopharyngeal swabs. Conclusion: Ag meets minimum criteria antigenic testing, satisfactory being used as device.

Language: Английский

---